BTZ-043 Dose Evaluation in Combination and Selection

Exclusion criteria

• ✕. The patient has a viral load (VL) \< 200 copies/mL on a test performed at screening
• ✕. The patient has a CD4 cell count \> 200 cells/mm3 at screening
• ✕. The patient is experienced on antiretroviral therapy (ART), and is on a combination of tenofovir, lamivudine and dolutegravir (TDF/3TC/DTG) for a minimum of 6 months prior to the screening visit.
• ✕. Clinically significant evidence of severe or extra-thoracic TB (e.g., miliary TB, TB meningitis, excluding limited lymph node involvement)
• ✕. Serious lung conditions other than TB or significant respiratory impairment in the discretion of the investigator
• ✕. Peripheral neuropathy (as evaluated by the Brief Peripheral Neuropathy Score).
• ✕. Significant psychiatric disorder like depression or schizophrenia; especially if treatment for those has ever been required in the last five years or is anticipated to be required.
• ✕. An established diagnosis of diabetes mellitus.